FDA Considers Shift on Device Quality System Regulations

Regulatory NewsRegulatory News | 27 February 2018 |  By 

A US Food and Drug Administration (FDA) spokeswoman told Focus on Wednesday that as part of global harmonization efforts around quality management systems, the agency is considering adding clauses from ISO 13485:2016 to the appropriate US medical device regulatory requirements.

The idea of such a move has generated lots of discussion among regulatory professionals on RAPS’ Regulatory Open Forum, centering around the question of whether it’s a fact or lingering rumor that FDA is moving in this direction.

FDA press officer Stephanie Caccomo told Focus via email: “With the publishing of the 13485:2016 revision, there has been industry evaluation of the regulatory requirement linkages to the standard. In the spirit of global harmonization of quality management systems, the FDA is considering an evaluation/mapping of the 13485 clauses to the appropriate U.S. regulatory requirements.”

So when is this evaluation or mapping going to occur? Caccomo said, “We cannot speculate on timing.”

According to an email posted to the RAPS Forum, FDA plans to publish a proposed rule in the spring of 2019 to align 21 CFR 820, which spells out medical device quality system regulations, and ISO 13485:2016.

And though a final rule may not come until 2020, the email said a transition period is expected to allow manufacturers to fully implement ISO 13485:2016.

The email said FDA faces logistical challenges, including revisions to multiple agency documents that reference 21 CFR Part 820 and training FDA investigators to audit against ISO 13485:2016. 

In addition, the nonprofit Association for the Advancement of Medical Instrumentation (AAMI) has conducted a survey on the feasibility and desirability of industry for transitioning from 21 CFR 820 quality system requirements to aligning with ISO 13485:2016 and a report on that survey is forthcoming.


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